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Sonographic and Laboratory Evaluation of the Thyroid Gland in Patients With Systemic Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01270425
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

Systemic sclerosis (SSc) is a systemic disease that involves various organs such as the skin, kidneys, gastrointestinal tract and lungs. Dysfunction of the thyroid gland is prevalent in these patients and may be related to thyroid fibrosis or to thyroid autoimmune disease, i.e. hashimoto's thyroiditis. Thyroid nodules are prevalent in the general population, although some reports suggest they might be more frequent in patients with SSc. Hashimoto's thyroiditis, by itself, carries a higher risk for thyroid nodules and thyroid cancer.

The aim of the study:To characterize sonographycally the thyroid gland of patients with SSc with and without Hashimoto's disease

Condition or disease
Systemic Sclerosis Hashimoto Thyroiditis Thyroid Nodules

Detailed Description:
The study protocol Fifty patients with SSc according to the current international classification will be included in the study. The patients, followed-up regularly in an out-patient clinic, will be tested for their thyroid function tests as well as the presence of thyroid auto antibodies. Clinical data will be collected from their medical records. Ultrasonographic examination of the thyroid gland will be performed by a single examiner. The gland will be characterized in detail with regards to its size and echotexture and cervical lymph nodes will be detected. The number and size of its nodules will be described as well as their echoic pattern (iso, hyperechoic or hypoechoic) calcifications (micro and macro), and borders status. Large nodules (≥ 1 cm in diameter) or with malignancy- associated characteristics will be aspirated according to current clinical practice. Treatment will be given according to the cytology diagnosis. Thyroid hormone supplementation will be recommended when thyrotropin level >8 mIU/L or according to clinical judgment of the investigators.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sonographic Characterization of the Thyroid Gland in Patients With Systemic Sclerosis With and Without Hashimoto Thyroiditis
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : November 2012

Primary Outcome Measures :
  1. There are no spesific outcome measures from trail [ Time Frame: Nnone ]
    the measures from trail are equal to vast population

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with SSc according to the current international classification

Inclusion Criteria:

  • Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

  • non

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01270425

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Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
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Principal Investigator: Pnina Rotman-Pikielny, MD Meir Medical Center, Israel
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Responsible Party: Meir Medical Center Identifier: NCT01270425    
Other Study ID Numbers: MMC11175-10CTIL
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: March 2012
Keywords provided by Meir Medical Center:
systemic sclerosis
hashimoto thyroiditis
thyroid nodules
Additional relevant MeSH terms:
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Thyroid Nodule
Scleroderma, Systemic
Scleroderma, Diffuse
Thyroid Diseases
Hashimoto Disease
Pathologic Processes
Endocrine System Diseases
Connective Tissue Diseases
Skin Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Thyroiditis, Autoimmune